Major Oral Peroxide (Axcentria) – Unstable Expiration (2012)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03
Brand
Axcentria Pharmaceuticals LLC
Lot Codes / Batch Numbers
Lot #s L11065, exp 12/2013, B12019, exp 2/2014, B12020, exp 2/2014, and D12035, exp 4/2014.
Products Sold
Lot #s L11065, exp 12/2013; B12019, exp 2/2014; B12020, exp 2/2014; and D12035, exp 4/2014.
Axcentria Pharmaceuticals LLC is recalling Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals due to Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-m. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MI
Page updated: Jan 7, 2026